MAUDE Adverse Event Report: DERMA SCIENCES, INC. LAPAROTOMY SPONGES, XRAY DET - 18" X 18", 4 PLY

Catalog Number 1213

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported there is dirt visible in the laparotomy sponges.Issue was detected prior to use.The items are stored in a climate controlled sterile supply storage room.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d9, g3, g6, h2, h3, h6, h10 laparotomy sponge was returned for evaluation.Dhr review: dup1213 with lot#4102920 was produced during (b)(6) 2021.The production process was under control without change on equipment, environment, material and product configuration, no abnormity was found during start-up verification.Failure analysis: the dirt that is on the sponge is the oil from the folding/pressing machine where there is oil leaking around the hydraulic cylinder.A retain sample of this complained lot was reviewed, the appearance was good without abnormity/dirt in sponge.Root cause: based on the analysis, the root cause is due to the sealing ring of the hydraulic cylinder worn out which caused oil leaking around the cylinder area.During the folding and pressing process of the lap sponge, the lap sponge had contacted the cylinder and contaminated with oil.A corrective action was implemented.

• Brand Name: LAPAROTOMY SPONGES, XRAY DET - 18" X 18", 4 PLY
• Type of Device: LAPAROTOMY SPONGE
• Manufacturer (Section D): DERMA SCIENCES, INC.; 104 shorting road; 104 shorting road; toronto, ontario M1S 3 S4; CA M1S 3S4
• MDR Report Key: 12316655
• MDR Text Key: 266383669
• Report Number: 9680091-2021-00010
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1213
• Device Lot Number: 4102920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1